510k
Database
Specialties
Anesthesiology
140
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578
Chemistry
167
Dental
324
Ear, Nose, Throat
68
Gastroenterology & Urology
294
General & Plastic Surgery
534
General Hospital
382
Hematology
67
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58
Medical Genetics
0
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234
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173
Obstetrics & Gynecology
67
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52
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1302
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18
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88
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887
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
136
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
87
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
84
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
83
JAK
System, X-ray, Tomography, Computed
79
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Annalise-Ai
Medical Device Manufacturer
·
AU , Sydney
Annalise-Ai - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2022
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Annalise-Ai
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 23, 2025
Annalise Enterprise
K250831
·
QFM
Radiology
·
35d
Cleared
Feb 24, 2022
Annalise Enterprise CXR Triage Pneumothorax
K213941
·
QFM
Radiology
·
70d
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2
Radiology
2